Pack of TEN: Best Selling Medical Devices Webinars by GlobalCompliancePanel

Webinar Pack
Pack of TEN: Best Selling Medical Devices Webinars by
GlobalCompliancePanel

Actual Price:
$2950.00

Your Price:
$1095.00

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Design History File (DHF), Device Master Record
(DMR), Device History Record (DHR) and Technical File
(TF) - Regulatory Documents Explained
The FDA QSR and the Medical Device Directive specify certain
Instructors:
documents or records that should be included in your organization's
quality systems - Design History File (DHF), the Device Master
Record (DMR) the Device History Record (DHR), and the Technical
Jeff Kasoff
Director of Regulatory
File (TF).
Affairs, Life-Tech, Inc

DHF, DMR, DHR, Technical File and Design Dossier -
Jeff Kasoff, RAC, is the Director of
Key Requirements and Future Directions
Quality at Byrne Medical, a leading
This webinar will examine the existing and proposed requirements
manufacturer of endoscopy
for the FDA's DHF - including its derivative documents, the DMR and
products. ..more
DHR.

John E Lincoln
Interfacing Design Verification, Process Validation and
Consultant, Medical device
Design Validation
and Regulatory affairs

There is confusion between the requirements for Design

John E. Lincoln is a medical device
Verification, Process Validation and Design Validation.
and regulatory affairs consultant. He
has helped companies to implement
Device Changes and the 510(k)
or modify their GMP systems and
The majority of medical devices are cleared for marketing in the U.S.
procedures. ..more
by the FDA under the 510(k) process.

Edwin L Bills
FDA's New Enforcement of 21 CFR Part 11
Principal Consultant, Bilanx
FDA's new Part 11 regulation takes quite some time, but inspectors
Consulting LLC
go out and inspect computer systems and e-records for compliance

with GMPs and most recent Part11 interpretations.

During his 20 year career in medical
devices, Mr. Bills has held a number
of quality and regulatory affairs
The 510(k) Submission: Requirements, Contents, and
positions. ..more
Options

This presentation will provide an understanding of how to get a
Dr. Ludwig Huber
device requiring a 510(k) submission to market quickly.
Chief Advisor - Global FDA
compliance, Agilent
The New FDA-Product Approval, Inspection, and
Technologies
Enforcement

The US Food and Drug Administration has recently released
Ludwig Huber, Ph.D., is Director of
information about its new strategies as a result of the new
Labcompliance and Chief Advisor for
global FDA compliance at Agilent
administration.
Technologies. ..more

Product Risk Management - ISO 14971:2007
Albert Cefalo
This webinar will address the use of the ISO 14971 model to
Regulatory Affairs Specialist,
perform and document such activities and the additional actions
Analogic Corporation
necessary to make it a useful product reference and training tool.

Albert Cefalo, Regulatory Affairs
Design History Files: Their Content and Control
Specialist, Analogic Corporation.
After attending this presentation the attendee should come away
Chuck has a BS degree from
with a good knowledge of what the requirements for Design History
Franklin Pierce College and a
Graduate certificate in RA from
Files are from both a domestic and international perspective, how
Northeastern University...more
to minimize DHF content so that the requirements are still.

Complaint Handling in Compliance with FDA and ISO
Regulations
Your Necessity is our Priority
This session will include the requirements for defining, documenting,
and implementing a complaint-handling system, including the
requirements for complaint review, investigation, and corrective
action, as well as the ISO-specific implications.

Click here to buy the webinar pack
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benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,
Event-coordinator
GlobalCompliancePanel

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About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online
compliance training by creating a single window of learning opportunities for compliance professionals & providing a
forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our
commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training
sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions,
giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.
GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning
and development on/through our website. Keep track of all webinars arranged for your industry through notifications &
event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
professionals.
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www.globalcompliancepanel.com
1000 N West Street Suite,
1200 Wilmington DE 19801

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